Cobra is a well established and experienced biologics manufacturer with the capability to fill antibodies (mAbs), recombinant proteins, plasmid DNA, as well as small molecules. Cobra's facility in Matfors, Sweden specializes in aseptic filling using modern, fully automated and disposable systems. It's track record of successful drug product delivery ranges in batch size from 3.5L to 50L or more.
Historically, the filled products have been manufactured from low cost, small molecule APIs where up to 1L of product waste was acceptable, for example, from line losses and integrity testing of filters.
However, since Cobra bought the site in 2011 biologics filling has increased significantly and a new process was needed to reduce product wastage with such high value materials. In order to accommodate these high value biologics APIs in small volume fills, a project was initiated to minimize product losses.
An initial paper exercise was carried out involving careful mapping of the fill process which then identified small changes in the working procedure and the choice of disposables that could have a significant impact on product losses. A plan was put in place to implement the changes and this resulted in a more than 10-fold decrease in product waste.
Conclusion and Outlook
With high value biologics such as antibodies (mAbs), recombinant proteins and plasmid DNA any wastage needs to be kept to a minimum. Having demonstrated that product losses can be minimized to less than 100mL with small changes to the current process, Cobra's on-going project will be to further minimize volume losses, enhancing customer product yields, by a thorough review of drug product sampling and validation procedures.
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